Carvedilol for Psychostimulant Dependence

This study has been completed.
Sponsor:
Collaborators:
Baylor College of Medicine
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01171183
First received: July 27, 2010
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

This study examines whether carvedilol prolongs abstinence in recently abstinent cocaine dependent participants.


Condition Intervention Phase
Cocaine Dependence
Cocaine Withdrawal
Drug: controlled release carvedilol
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of Carvedilol for Psychostimulant Dependence

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • urine toxicology screens [ Time Frame: thrice weekly for 12 weeks ] [ Designated as safety issue: No ]
    cocaine use, as measured by thrice-weekly urine toxicology screens


Secondary Outcome Measures:
  • retention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    number of weeks each participant is on study protocol


Enrollment: 32
Study Start Date: August 2010
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo
Active Comparator: Carvedilol controlled release
controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing
Drug: controlled release carvedilol
carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper
Other Name: Coreg CR

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-45 years old
  • Cocaine dependence, as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV.
  • At least weekly self-reported cocaine use during a preceding three month period
  • Urine toxicology screen positive for cocaine or cocaine metabolite
  • Women of childbearing age must have a negative pregnancy test, agree to adequate contraception to prevent pregnancy during the study, agree to monthly pregnancy testing and not be nursing

Exclusion Criteria:

  • Suicide attempts within the past 12 months or suicidal ideations or psychotic symptoms in the past 6 months as determined by a study physician.
  • Current opioid, alcohol or sedative physical dependence or amphetamine dependence.
  • Major cardiovascular disorder that contraindicates study participation (e.g., history of myocardial infarction, stroke, congestive heart failure, cardiac arrhythmia, significant hypertension [i.e., >170 SBP or >110 DBP] or an unstable medical condition (e.g., untreated bacterial infection) as determined by the study physician.
  • Asthma or chronic obstructive pulmonary disease.
  • History of schizophrenia, or bipolar type I disorder.
  • Use of medications that would be expected to have major interaction with carvedilol (e.g., rifampin, cimetidine, digoxin, diuretics).
  • Medical contraindication to receiving carvedilol (e.g., diabetes, severe bradycardia, bronchial asthma or other bronchospastic condition, 2nd or 3rd degree AV block, sick sinus rhythm, severe hepatic impairment, documented hypersensitivity to carvedilol).
  • Patients currently taking selective serotonin re-uptake inhibitors, antipsychotics and antidepressants (e.g., amitriptyline and imipramine).
  • Liver function tests (i.e., liver enzymes) greater than three times normal levels.
  • Systolic blood pressure > 170 mmHg or < 90 mmHg, diastolic blood pressure > 110 mmHg or < 60 mmHg, or heart rate of > 110 beats/min or < 55 beats/min. Supine blood pressure of 100/65 mm Hg or lower, a seated blood pressure of 90/60 mm Hg or lower, or an orthostatic change of >20mm Hg systolic or 10 mm Hg diastolic on standing.
  • Participants with estimated glomerular filtration rate < 30 ml/min.
  • Pregnant or nursing female.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01171183

Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Baylor College of Medicine
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01171183     History of Changes
Other Study ID Numbers: 2 P50 DA018197, 2P50DA018197
Study First Received: July 27, 2010
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Arkansas:
cocaine dependence
cocaine withdrawal

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on September 18, 2014